FDA 510(k) Applications Submitted by Susanne Galin

FDA 510(k) Number Submission Date Device Name Applicant
K100283 02/01/2010 VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC COOK, INC.
K120468 02/16/2012 NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR COOK INCORPORATED
K130444 02/21/2013 H-30 HOLMIUM LASER SYSTEM COOK, INC.
K090624 03/09/2009 COOK MREYE EMBOLIZATION COILS COOK, INC.
K100974 04/08/2010 SPECTRUM TURBO-JECT PICC SET COOK INCORPORATED
K081113 04/18/2008 COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS COOK, INC.
K211238 04/26/2021 SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement Stryker Instruments
K081768 06/20/2008 COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES COOK INCORPORATED
K072148 08/03/2007 CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER COOK, INC.
K172367 08/04/2017 Stryker Integrated Bipolar Cord and Tubing Sets Stryker Instruments
K093469 11/06/2009 CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS COOK, INC.


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